Before launching a new health-related feature on one of its products, Apple must obtain approval from the Food and Drug Administration (FDA) in the United States. This particularly applies to features that involve medical diagnostics, health monitoring, or any other function that may have an impact on the health of users. This ensures that the features meet medical safety and effectiveness standards. Apple announced it at the Apple Event on September 9: the Apple Watch Series 10, Series 9, and Ultra 2 will benefit from sleep apnea detection!
Apple gets green light just before Apple Watch Series 10 launches
Today, the Food and Drug Administration (FDA) The US government has given the green light to a new feature that will revolutionize connected health: sleep apnea detection on Apple Watch. This new feature will be integrated into the Apple Watch Series 10, Apple Watch Series 9 and Apple Watch Ultra 2 models, and will be available in more than 150 countries, including France, starting this month.
Sleep apnea is a common but potentially serious disorder in which breathing repeatedly stops and starts during sleep. This can lead to high blood pressure, heart disease, and excessive fatigue, which greatly increases the risk of accidents and long-term health complications. In other words, if sleep apnea is not treated promptly, it can have serious consequences.
The detection feature is specifically for adults ages 18 and older who have not yet been diagnosed with sleep apnea. It leverages the capabilities of the Apple Watch accelerometer, which detects subtle movements associated with breathing disturbances during sleep.
Users will be able to track their breathing disorders directly in the Health app on their iPhone, where disturbance levels will be categorized into two categories: “elevated” or “not elevated.” Using advanced machine learning, this feature has been tested and validated through a rigorous clinical study.
And in France?
As far as France is concerned, theNational Agency for the Safety of Medicines and Health Products (ANSM) has already given its approval for sleep apnea detection on Apple Watch. This means that we won’t have to wait for the feature to launch on Apple Watch Series 10, 9 and Ultra 2, it will be available at the same time as other countries!
